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Antibiotic Alert: The Drug The Doctor Ordered Could Cause Deadly Side Effects

One of Many Educational Campaign Alerts Warning of Quinolone Reactions

A couple of months ago I took my teenage daughter to the doctor for an ear infection, and came home with a prescription for the antibiotic Cipro. I’ve taken it before myself, and thought nothing more about it – until I read the fine print in the insert that said it wasn’t recommended for patients under 18. That made me call the advice nurse, who assured me there was nothing to worry about. It also made me dig a little deeper, and start asking questions.

And then a couple of weeks ago the New York Times came out with a scary blog post about Cipro and related antibiotics, and I really began to wonder.

The Frightening History of Fluoroquinolones

Some of this isn’t news, exactly. (Except that the message doesn’t seem to be getting through.) For at least 15 years, patients, doctors and pharmacology experts have been warning about the dangerous and potentially deadly side effects of fluroroquinolones, often referred to as quinolones or FLQs in the health field.

Fluoroquinolones are extremely powerful antibiotics, developed to treat serious respiratory tract infections such as hospital-induced pneumonia, and other antibiotic-resistant or potentially deadly infections. (Cipro received major press when it was prescribed to postal workers and soldiers to prevent anthrax infection.)

Infectious disease experts consider them to be an antibiotic of last resort, to be prescribed only when first-line antibiotics such as penicillin fail to work, or in cases of extreme, life-threatening infection, or for certain bacteria known to respond best to quinolones. However, many doctors now go to Cipro and Levaquel first, prescribing them for ear infections, sinus infections, urinary tract infections, and many other common bacterial diseases.

The most common American antibiotics in this class are Cipro (Bayer). Levaquin (Johnson & Johnson), and Avelox (Bayer) – generics are ciprofloxacin, levofloxacin, and moxifloxacin, and others with the word “flox” in them. Lots of antibiotics have side effects, but what makes quinolones so much riskier is that the side effects caused aren’t necessarily temporary; they can cause severe and permanent disability.

Just a few listed on the drugs’ warning labels or named in studies:

Toxic Psychosis

Neuropathy

Retinal Detachment

Tendon Rupture

Muscle Damage

Seizures

Heart Arryhthmias

Abnormal Liver Function

Kidney Damage

Neurotoxicity was one of the first side effects reported. As far back as 2001, Indiana University Professor David Flockhart, considered one of the foremost experts in fluoroquinolone-related side effects, published research linking quinolones to neurotoxicity.

Flockhart also had this to say: “…as many as a third of patients taking a fluoroquinolone will experience some sort of psychiatric side effect, such as anxiety, personality change or confusion…The psychiatric effects of the fluoroquinolones are underappreciated by the medical profession as well as by the public.”

Also in 2001 Jay Cox of the University of California, San Diego, published research demonstrating the potential of fluoroquinolones to cause peripheral neuropathy. Since then, Cox since then has been documenting “terrible, catastrophic reactions” to Cipro, Levaquin and other drugs in the class in a newsletter.

Even earlier, in his 1998 book Bitter Pill, journalist Stephen Fried documented his wife’s reaction to Floxin, one of the earliest of the quinolones (now pulled from the market), and his family’s journey to get her condition recognized and treated.

Cipro and Levaquin now carry “black box” warnings for tendon rupture and for the potential to exacerbate the autoimmune condition myasthenia gravis.

The Numbers

The statistics on adverse reactions to Cipro, Levaquin and others aren’t considered complete because of the way the FDA’s database is constructed; the FDA considers its system to reflect about 10 percent of the actual incidence. Even so, there have been 2,500 documented deaths resulting from the major quinolones and 45,000 cases of side effects. Websites like Hurt by Levaquin and Surviving Cipro have sprung up as forums for those who consider themselves victims of the drugs.

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I can’t thank you enough for writing this article. I am a victim of the side effects from levaquin. It almost cost me my life. I took it for 10 days as prescirbed and by 30 days I was bedridden by 120 days my family was told there was no hope for me that I was in “Gods” hands now. But by the grace of “God” I did survive but I was almost like a vegetable. I spent over 3 months in hosptials, have had and will continue to have a lot of physical and occupational therapy. I have have had to learn everything over just like a baby, from learning to swallow again to sitting up again. I am 18 months out of the hospital and still do not have all my muscular movements back yet and am still in a wheelchair. I spent over a year on a hoyer lift because I could not even stand. I pray everyday that the FDA will change they way they approve the medications and that no other person will have to go thru the agony and pain that me and my family have gone thru. This has cost me my job of over 30 years in the mortgage banking business and has put a financial/emotional strain on my family and also my friends that have been with me thru this journey. There is a heart logo that is being used in reference to Antibiotic Awareness. My daughter created that logo when I was in the hospitals. She is a founding member of the Antibiotic Awareness Organization here in Texas. They are holding a 5K run/walk in the Galleria area here in Houston on November 3, 2012. If we can stop even 1 person from having to go thru what we have been thru, then we have achieved our goal. But we really want this to be on a much larger scale because this affects “EVERYONE”. Thank You again for bringing this awareness to the general public.

This drug sent my mother in law on a downward spiral to her death. She was recovering from pneumonia nicely. But a blood test showed slight bladder infection. They started administering the drug on a Friday. It was piggy backed in her IV. Three bags. Immediately she started complaining that it felt like the top of her head was exploding. I got concerned. She was 79 and diabetic. Then she started hallucinating, seeing things, talking out of her head. I went to her pharmacist and he printed out possible serious reactions. I could not get in touch with the doctor as it was the weekend. Kept giving the drug all weekend. By Monday she was almost comatose. Transferred her to another bigger hospital and under my husband’s physician as he primary was out of the country and she was being cared for by an associate. Her death was stated as RDS. Everything just started shutting down. We could not sue in the state of Florida. Only a dependent child or spouse can in that state. (how convenient) So I contacted the drug company. I gave them complete access to her medical records from the day she was admitted. I filled out a form stating all her complaints and behavior. I thought, maybe I can save someone else this horror. This drug should be taken off the market. And any of the other Floxin drugs that have this capability. And god forbid if they get permission to use it in pediatrics. Can you just imagine the horror.

What is old and tired is trying to get anyone in the medical profession to recognize that they are destroying a substantial number of their patients lives. This is a curse worse than cancer and yet no one is researching what can be done to help the victims, no one is acknowledging this is even happening. We see doctor after doctor after doctor and at least in my case the problems are real and obvious and require surgery after surgery after surgery and still no one is able or willing to connect the dots and then do something about it. A list of my problems reads almost exactly the same as the warnings in the product literature. That’s the thing about these rotten drugs is that if you have a reaction you usually react from head to toe; it is pure hell. The worst thing to ever happen to me hands down. What may seem like old news to you was for the victims of this corporate greed the best news to come along in our lifetimes. This story is finally getting traction and is about to blow wide open. Every paper, every TV station is going to get on the bandwagon. At least they will if we have anything to say about it and you’ll never find a more dedicated group of people. We want to make sure that no one goes through the horror that we’ve been through again. This drug needs to be removed from the market or at the very least curtailed to something like a hundredth of one percent as often as it is prescribed now.

I do understand this subject has been covered quite a bit. However, somehow the word is not getting out at the doctor/patient/pharmacist level, at least not to the degree it should be. If we had resolved the issue, these drugs would not be being prescribed for routine illnesses, and patients would be warned to watch for these side effects and report them immediately. Sometimes public health messages have to be repeated numerous times before they become effective.

Thank you! you bring up some incredible points. While it may be old and tired news for some–we live this everyday of our lives. If they are feeling the news is old and tired–how the heck do we feel? Nothing is the same for us and it never will be, yet big pharma seems to rest quite well at night, as do the doctors who prescribe this medication.

Fluoroquinolones (FQs) can make you “Old, tired”; most people and MDs do not know this; the damage and death continue. This is an important article. Why does this toxicity continue to happen if everyone knows about it?

Thank you Melanie and Forbes!

Below I listed some valuable scientific papers regarding fluoroquinolones that you might be interested in reading?

Leone et al. examined FQs side by side in comparison to other antibiotics in a large sample. FQs were far more dangerous than alternative antibiotics (significantly so, and the damage was in multiple body systems).

Nearly 20 years ago Lawrence et al. demonstrated that FQs deplete and mutate mammalian mitochondrial DNA. The FDA does not check for this damage in their drug approvals. Believe me you want to protect the health of your mitochondrial DNA.

Pharmageddon is real and it is very important to share information that can save our health and lives.

Thank you very much for these additional resources. I’ve read several of these studies and they’re alarming; some I hadn’t seen yet. Cohen’s research was some of the earliest and he has been quite persistent in calling attention to the mounting anecdotal evidence of severe individual reactions to fluoroquinolones.

Old and tired….. Spoken by someone who is not affected or know an affected person. Like many have said, nobody knows about it. How can it be old and tired? I bet you less than 2% of the population is aware of this, so efforts must be kept to raise awareness and fight for this cause until some justice is served… I truly appreciate the help this article brings and quite frankly, why read the article + comment on it, if already aware?

I now spend every waking minute of my life, trying to study to find a way to cure my condition because there otherwise I have no life left. Although public interest may go away in this topic, our condition will not…

after only four 500 mg pills of Levofloxacin …yes I feel OLD and TIRED and my symptoms Do repeat themselves. I wouldn’t wish this on anyone, but you really shouldn’t be such a smart a$$ it COULD happen to you or someone YOU LOVE, and if ,god forbid ,it does- you are going to need us …as we may be the only ones who believe you

Ronald Kavanagh was a drug reviewer for the FDA in the Center for Drug Evaluation and Research from 1998 to 2008. In a recent interview he reveals how the FDA bypassed or ignored safety issues on major drugs approved during his employment. In an interview for the online news magazine Truth-Out he tells Martha Rosenberg1:

“In the Center for Drugs [Center for Drug Evaluation and Research or CDER], as in the Center for Devices, the honest employee fears the dishonest employee.

There is also irrefutable evidence that managers at CDER have placed the nation at risk by corrupting the evaluation of drugs and by interfering with our ability to ensure the safety and efficacy of drugs. While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees.

In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug’s approval – which of course was our job as drug reviewers – management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.”

According to Kavanagh, people would be shocked if they knew just how malleable safety data is. As examples, he points out that human studies are typically too short and contain too few subjects to get a clear picture of potential risks. In such a scenario, even a single case of a serious adverse event must be taken very seriously, and data from other longer term safety studies also need to be carefully analyzed. Kavanagh claims he has seen drug reviews where the medical safety reviewer completely failed to make such evaluations prior to the drug’s approval